WASHINGTON – AACC is pleased to see an additional $2 million for lab test harmonization in the FY 2018 omnibus spending package. The association has worked to advance harmonization – or uniform test results -- for more than a decade, most recently leading efforts to raise awareness in Congress of the need for CDC funding for harmonization. AACC is gratified that its multiyear effort has resulted in a positive outcome. The new funding will enable CDC to broaden its harmonization initiative, which is vital to ensuring that patients receive accurate diagnoses and effective medical treatment.

Lack of lab result harmonization is a serious concern in the healthcare system, leading to unnecessary spending and suboptimal patient outcomes. Without harmonization, patients’ lab results can be different depending on where their tests were performed and what diagnostic methods were used. Harmonizing test results is crucial to ensuring that patient lab results can be compared over time and used to accurately monitor changes in health even if, for instance, the patient switches providers or the provider’s lab changes instruments. Ensuring uniform test results also reduces healthcare costs. The foremost example of this is CDC’s Lipids Standardization Program, which harmonizes cholesterol test results and has generated savings ranging from $338 million to $7.6 billion per year since its inception in the 1980s. Unfortunately, very few lab tests have been harmonized in the same way.

With this $2 million in funding for 2018, CDC will now have the resources to advance harmonization for free testosterone, thyroid stimulating hormone, and estrogen. This will involve providing materials to and monitoring laboratories and manufacturers across the country to improve the accuracy and precision of their test measurements. Ultimately, these efforts will improve diagnosis, treatment, and preventative measures for diseases such as polycystic ovary syndrome, hypothyroidism, chronic kidney disease, and osteoporosis.

AACC spearheaded the multi-year collaborative initiative to secure Congressional funding toward this aim. AACC has worked extensively to educate lawmakers about the issue by holding briefings on Capitol Hill, regularly discussing harmonization with Congressional offices, and collaborating with Rep. Kevin Yoder (R-Kan.), who championed the issue with House and Senate appropriators. The association also created a partnership of 17 clinical associations and laboratories in support of harmonization funding, and previously released a white paper and position statement on the subject.

“We at AACC are thrilled that Congress has provided this funding for an expanded CDC harmonization program,” said AACC CEO Janet B. Kreizman. “Patients and their physicians should be free to think about the clinical implications of test results and not about whether differences in test results are due to different labs performing those tests. AACC would like to thank the legislators involved in this decision, especially Rep. Yoder, and we urge Congress to award additional funding to CDC in future years so that the agency can continue to build on what it accomplishes in 2018.”

About AACC

Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.